The goal of this observational cross-sectional study is to determine the salivary levels of E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 (MMP-9) in patients with Recurrent Aphthous Stomatitis (RAS) and to compare them with those of healthy controls.
The main questions it aims to answer are:
Are the salivary levels of E-cadherin, Calprotectin, and MMP-9 significantly different in patients with minor RAS compared to healthy controls?
Can these salivary proteins serve as biomarkers involved in the pathogenesis of minor RAS?
Researchers will compare patients with minor RAS and healthy individuals to determine whether differences in salivary E-cadherin, Calprotectin, and MMP-9 levels are associated with the presence of disease.
Participants will:
Provide unstimulated saliva samples using a saliva swab
Undergo clinical evaluation for periodontal status (Community Periodontal Index - CPI) and caries experience (DMFT index)
Collected saliva samples will be stored at -80°C until analysis. The concentrations of the investigated proteins will be measured using ELISA kits, and total protein levels will be determined using a colorimetric protein assay.
The relationships among the salivary concentrations of the investigated proteins, as well as their associations with demographic variables such as age and sex, will be analyzed.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants aged 18 years or older
* Clinically diagnosed with minor recurrent aphthous stomatitis (RAS) (defined as having a history of at least three RAS episodes within the past year)
* Systemically healthy (i.e., without any diagnosed systemic disease)
* No history of tobacco use
* Presence of at least one active aphthous ulcer at the time of saliva sample collection
* No known mental or physical disabilities
Exclusion Criteria:
* Use of any pharmacological treatment within the past 3 months
* Use of antiseptic mouthwash within the past 3 months
* Pregnant or lactating individuals, or those currently using oral contraceptives
* History of systemic diseases associated with oral ulcerations such as Crohn's disease, ulcerative colitis, celiac disease, or Behçet's disease
* History of chemotherapy or radiotherapy
* Current or prior use of immunomodulatory drugs, cytotoxic agents, or systemic corticosteroids
* Undergoing orthodontic treatment (to avoid misdiagnosis with traumatic ulcers)
* Use of removable dental prostheses (to avoid misdiagnosis with traumatic ulcers)
* Presence of periodontal disease (CPI score of 3 or 4)
* Caries risk not classified as very low (DMFT ≥ 5)
* Presence of pathological oral mucosal lesions such as lichen planus, pemphigus vulgaris, or mucous membrane pemphigoid
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Salivary Concentrations of E-cadherin, Calprotectin, and Matrix Metalloproteinase-9 (MMP-9) Using ELISA